Drug Regulator Issues Show Cause Notice To Hetero Labs After US FDA Notes Hygiene Lapses

The country’s apex drug regulatory agency, Central Drugs Standard Control Organisation (CDSCO), has issued a show-cause notice to drugmaker Hetero Labs after the company failed to submit mandatory details relating to GMP violations identified during a recent inspection by the American drug regulator, United States Food and Drug Administration (US FDA).

The notice was sent to the company’s Unit-IX facility at Hetero Infrastructure SEZ in Anakapally, Andhra Pradesh.

The regulator said the communication was issued “with reference to the non-compliance related to good manufacturing practices (GMP) violation found during the inspection of US FDA on 19-26 September, 2025.”

The letter, accessed by News18, said: “In the event of any non-compliance observed

during inspections conducted by local or international drug authorities, the same shall be forwarded to this office within seven days of receipt of report.”

The CDSCO said Hyderabad-based Hetero Labs did not meet that requirement. “You have failed to furnish the information within 7 days of receipt of the report,” the letter said.

The agency has now asked the company to explain why its written confirmation should not be withdrawn and why regulatory action should not be initiated. The notice said: “You are, therefore, given an opportunity to explain your position in this regard and notice as to why your written confirmation may not be withdrawn and an action deemed necessary under the provisions of Drugs and Cosmetics Act and Rules may be undertaken against you.”

It further instructed the company to respond promptly. “You are hereby directed to submit your reply within 10 days from the date of issue of this letter to this office; otherwise it will be presumed that you have nothing to say in the matter.”

Copies of the show-cause notice were circulated to the CDSCO’s Visakhapatnam sub-zone office and Hyderabad zone office.

Hetero Labs Responds

In an emailed response to News18, a Hetero spokesperson said, “Hetero has already responded to the CDSCO as a standard practice and as per the process.”

“As we earlier conveyed (for a news story based on US FDA findings), we are addressing the FDA observations through the regulatory framework and we remain fully committed to implementing all necessary measures in a timely manner as necessary and as required by the regulatory agencies.”

“And we reiterate, at Hetero Labs, we hold patient safety and regulatory excellence in the highest regard and we are in touch with all stakeholders.”

US FDA Flagged Birds, Lizards And Filthy Conditions

News18 earlier reported the FDA inspection between September 19 and 26. The American agency found birds flying inside warehouse buildings, bird droppings on top of storage drums, nests lodged in upper seams, and crawling lizards in areas where active pharmaceutical ingredient drums were stored. Inspectors also reported filthy conditions and inadequate pest control measures in parts of the facility, noting serious lapses in hygiene and storage practices.

The report described how inspectors were refused entry for approximately two hours, during which “a truck full of drums had left the facility without any explanation provided”, and another incoming truck “was turned away by the security officers upon their indicating our presence at the facility”.